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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The Blowfish Transbronchial Micro-Infusion Catheter is a bronchoscope-guided device that contains a perpendicular stainless steel micro-needle port. This port is sheathed by and contained within a semi-rigid polymer actuator, which is connected to the flexible shaft. At the proximal end of the catheter shaft is the hub assembly.
MERCATOR MEDSYSTEMS, INC.
MDL09-0616-145-34
Not in Commercial Distribution

  • M973BH201M1 ()
BH201M

  • Vascular microcatheter
  • Bronchial balloon catheter
A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. The Oxygen Holder is an accessory that attaches to a medical device to hold an oxygen tank.
Pride Mobility Products Corp
Oxygen Holder
In Commercial Distribution

  • 00606509800006 ()
N/A

  • Wheelchair medical gas supply holder
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Movair, Inc.
3080N
Not in Commercial Distribution

  • 10814321020176 ()
  • 00814321020179 ()


  • Electromagnetic blood flowmeter
The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38P.
Movair, Inc.
3090N
Not in Commercial Distribution

  • 10814321020152 ()
  • 00814321020155 ()


  • Electromagnetic blood flowmeter
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5050
In Commercial Distribution

  • EAMIICT50500 ()


  • Basic power supply, reusable
The i-Cut system is indicated for morcellating and extracting tissue in laparoscopic, gynecologic surgical procedures. The i-Cut is electrically operated by a DC Motor which is powered by a 24V AC/DC mains adapter. The non-sterile i-Cut Power Supply with power cord is supplied separately to power the device.
AMI Agency for Medical Innovations GmbH
ICT5010
In Commercial Distribution

  • EAMIICT50100 ()


  • Basic power supply, reusable
6' Electrode Lead Wire Set for use with the Uroval BRS System.
UROVAL, INC.
BR5338 UDI Not Req as is component
In Commercial Distribution

  • 00852523007024 ()

  • Length: 6 Feet


  • Analytical non-scalp cutaneous lead
CitriSol Dry Concentrate for Bicarbonate Dialysis
DIASOL, INC.
CSP45225-75100
In Commercial Distribution

  • B467CSP4522575100 ()
  • B467CSP452257510016 ()
CSP3

  • Haemodialysis concentrate
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
110
In Commercial Distribution

  • 00850011324110 ()

  • Height: 9 Millimeter
  • Width: 10 Millimeter
VAL-CA-10-09

  • Metallic spinal fusion cage, non-sterile
The L-Varlock is a lumbar cage, for intervertebral body fusion.
SPINESOURCE INC
004
In Commercial Distribution

  • 00850011324004 ()

  • Width: 13 Millimeter
  • Height: 8 Millimeter
VAL-CA-13-08

  • Metallic spinal fusion cage, non-sterile
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